Medhot Thermal Imaging, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Medhot Thermal Imaging, Inc. makes
Medhot Thermal Imaging, Inc. manufactures the Medhot MTI 2000 Thermal Imaging System, a device designed for non-invasive thermal imaging to detect temperature variations in tissues or surfaces.
The company’s portfolio is regulated under FDA’s Class I device classification, with the Medhot MTI 2000 cleared via the 510(k) pathway. The device is listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Med-Hot Thermal Imaging Systems Ref K171928
Regimes: 510(k) Registry: 510(k)Medhot Mti 2000 Thermal Imaging System Ref K063047
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Medhot Thermal Imaging, Inc., initiated on 2017-01-14. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 1
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2017
- 14 Jan 2017 Z-2057-2017 Class II Terminated Indications for use are not cleared or approved for market in the U.S.
Frequently asked questions
How many devices does Medhot Thermal Imaging, Inc. have in the registry?
The registry currently lists 2 devices for Medhot Thermal Imaging, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medhot Thermal Imaging, Inc.'s devices?
Among its 2 most recently registered devices, Medhot Thermal Imaging, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Medhot Thermal Imaging, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Medhot Thermal Imaging, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for Medhot Thermal Imaging, Inc.?
FDA recall records list 1 recall initiated by Medhot Thermal Imaging, Inc., the most recent initiated on 14 Jan 2017. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Medhot Thermal Imaging, Inc. in the registry?
The most recently registered devices listed for Medhot Thermal Imaging, Inc. include Med-Hot Thermal Imaging Systems and MEDHOT MTI 2000 THERMAL IMAGING SYSTEM.